Jane S. Ricciuti, RPh, MS


February 19, 2003

In This Article

Antihypertensive Agents

(candesartan cilexetil) Tablets

Manufacturer: AstraZeneca LP

Drug Approval Classification: Supplemental NDA (approval date: 1/22/03)

Adverse Effects: This supplemental NDA provides for 2 changes to the product labeling.

Under WARNINGS, Fetal/Neonatal Morbidity and Mortality, the following statement was added:

-- Postmarketing experience has identified reports of fetal and neonatal toxicity in babies born to women treated with Atacand during pregnancy.

  • Under PRECAUTIONS, General, Drug Interactions, new information regarding the administration of lithium and candesartan has been added that reads as follows:

    -- Lithium - Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors, and with some angiotensin II receptor antagonists. An increase in serum lithium concentration has been reported during concomitant administration of lithium with Atacand, so careful monitoring of serum lithium levels is recommended during concomitant use.

  • Atacand (candesartan cilexetil) Letter

    Atacand (candesartan cilexetil)

    Diovan HCT
    (valsartan/hydrochlorothiazide) Tablets

    Manufacturer: Novartis Pharmaceuticals Corp.

    Drug Approval Classification: Supplemental NDA (approval date: 1/15/03)

    Dosing: The Diovan HCT dose and administration guidelines were revised to recommend a starting dose of valsartan of 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume depleted.

    Diovan HCT (valsartan/hydrochlorothiazide) Tablets Letter

    Diovan HCT (valsartan/hydrochlorothiazide) Tablets


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